Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

Summary

The purpose of the study is to evaluate the efficacy and safety of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone and to assess the dose-response relationship, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF \[below 60%\]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR \[between ≥ 20 and ≤ 60 mL/min/1.73 m\^2, with at least 20% of participants with eGFR ≥ 20 to \<30 mL/min/1.73\^2 and a maximum of 35% of participants with eGFR ≥ 45 mL/min/1.73 m\^2\]).

Timeline

Start

2021-01-26

Primary completion

2023-09-22

Completion

2023-09-22

Outcome

Missed primary endpoint

registry analysis (other test); AZD9977 15 mg + Dapagliflozin 10 mg vs AZD9977 50 mg + Dapagliflozin 10 mg vs AZD9977 150 mg + Dapagliflozin 10 mg vs Dapagliflozin 10 mg; p = 0.3645; F test statistics 1.07; F-Test NCT04595370 ↗

Drugs

Indications